Dexmedetomidine and Postoperative Cognitive Dysfunction (POCD)

NCT ID: NCT06371638

Last Updated: 2024-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 112 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-07
• Study Completion Date: 2024-03-07

Brief Summary

Postoperative cognitive dysfunction (POCD) affects all age groups and can lead to increased morbidity and more extended hospital stays. Dexmedetomidine reduces POCD by inhibiting the increase in proinflammatory cytokines IL-6 and TNF-α, and its anti-inflammatory activity contributes to its protective effect. Previous studies found that dexmedetomidine reduced POCD incidence in non-cardiac and cardiac surgery. Therefore, the goal of this study was to specifically investigate if using TCI dexmedetomidine to maintain anaesthesia in laparotomy surgeries reduces the incidence of POCD compared to inhalation anaesthesia by sevoflurane.

Conditions

Postoperative Cognitive Dysfunction; Postoperative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Patients with POCD

MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.

Group Type: EXPERIMENTAL

Dexmedetomidine

Intervention Type: DRUG

General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml

Sevoflurane

Intervention Type: DRUG

General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.

Patients without POCD

MMSE was assessed 24h before surgery, 3 days after surgery, and 30 days before surgery. Subjects is considered to have POCD if the postoperative MMSE score was lower by at least 2 points compared to the preoperative score.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml

Sevoflurane

Intervention Type: DRUG

General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.

Interventions

Dexmedetomidine

General anaesthesia for subjects in Group D was maintained by target-controlled infusion (TCI) dexmedetomidine (Dyck mode) with target plasma of 1 ng/ml

Intervention Type: DRUG

Sevoflurane

General anaesthesia for subjects in Group I was maintained by inhalation anaesthesia using sevoflurane at 0.8% concentration.

Intervention Type: DRUG

Other Intervention Names

Group D; Group I

Eligibility Criteria

Inclusion Criteria

• Aged >= 18 years old
• Scheduled for laparatomy surgery

Exclusion Criteria

• history of allergies to anaesthetic drugs
• impaired consciousness
• neurocognitive disorder
• psychiatric disorder
• mental disorder
• cerebrovascular disorders
• sick sinus syndrome
• hypoalbuminemia
• massive bleeding
• liver disease
• kidney diseases.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Udayana University

OTHER

Sponsor Role: lead

Responsible Party

Christopher Ryalino, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Prof. Ngoerah General Hospital

Denpasar, Bali, Indonesia

Countries

Indonesia

Other Identifiers

2024-01

Identifier Type: -

Identifier Source: org_study_id